FDA, in collaboration with USP, continues to modernize many existing compendial monographs to support stakeholders on ensuring product quality and safety. USP and FDA recognized the need to replace an open digestion and non-specific titration procedure in the current Selenium Sulfide Topical Suspension monograph with up-to-date technologies. A method of quantifying selenium by ICP-OES after a two-step microwave digestion was developed which avoided direct handling of hydrofluoric acid (HF). HF was created <i>in situ</i> in the microwave digestion vessel by heating a mixture of ammonium difluoride, nitric acid, and sample for complete digestion of complex sample matrixes. Analytical characteristics including accuracy, precision, intermediate precision, specificity, linearity, system suitability, solution stability, and robustness were validated according to USP General Chapter &lt;1225&gt;. By incorporating ICP-OES and a closed-vessel microwave-assisted digestion, the method achieved increased specificity and sensitivity for selenium quantification to ensure product quality and greater laboratory safety. This joint effort between USP and FDA on monograph modernization helps stakeholders meet future regulatory standards and ultimately advance public health and safety.

FDA initiative on USP monograph modernization: Selenium quantification in antidandruff shampoo and lotion by inductively coupled plasma – optical emission spectrometry (ICP-OES) after microwave assisted digestion

254th National Meeting (2017)

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